By Dale Hockel and Denisa Lambert
In today’s hospital, there is a significant gap between hospital risk management and clinical engineering. Clinical engineers are hired to maintain, repair, and fix equipment, but they are often expected to oversee hospital risk management related to this equipment as well. In a typical hospital, there is not a sufficient number of engineers and techs to adequately cover the risk management role. This fact leaves many clinical engineers in a position where they must rely on previous experience and gut instincts acquired from years of experience in the field rather than following state and federal regulations precisely. But relying on industry experience alone for regulatory practice is not an accepted practice today, especially with more rigorous regulatory requirements like those of the Centers for Medicare & Medicaid Services (CMS), where a hospital’s reimbursement depends on its compliance with the most recent regulations.
In addition to the CMS regulations, clinical engineers must also contend with a wide range of other mandates and guidelines, including accreditation requirements (TJC, HFAP, DNV), state department of health rules, and equipment recalls and alerts from the FDA and original equipment manufacturers. Between the major federal and state governing bodies overseeing health care facilities, the number and variety of requirements that hospitals are expected to comply with every year can be overwhelming.
In such an environment, effective risk management nowadays requires a full-time professional to fully understand and be up to date on accreditation standards and state and federal regulations for every device in the hospital, in addition to having a plan in place to keep each device compliant at any given moment. Although experienced clinical engineers are in general well prepared for these responsibilities, many are not given the time needed to effectively engage with each regulatory body or to stay up to date with every device in the hospital.
In this article, we’ll talk about whose responsibility it is in the hospital as well as cover best practices for staying compliant.
Medical Equipment Management Plan
Compliance starts with a medical equipment management plan, as laid out by The Joint Commission: “The hospital has a written plan for managing medical equipment” (EC01.01.01, EP7 [A]). Best practices for such a plan include the following key components:
- The written plan and its supporting policies and procedures;
- The process for selecting, planning, and acquiring equipment;
- The process for addressing equipment use errors and medical device patient risks;
- Preventive maintenance of life-support and non-life-support equipment and documentation;
- Maintenance strategies and intervals;
- Procedures for responding to alerts and recalls;
- Compliance with Safe Medical Device Act (SMDA) requirements; and
- The process for evaluating effectiveness of the management plan and compliance with it.
The medical equipment management plan starts with accurate inventory management. The biggest (and sometimes most costly) mistake hospitals make in equipment management involves physical inventory—knowing what equipment you have, what its preventive maintenance schedule should be, how you utilize it, and so forth. Many times equipment listed in inventory in fact no longer exists, or is a duplicate listing. The most dangerous situation is when equipment is still in use but not accounted for. Not knowing critical information about your inventory puts the facility at risk with respect to regulatory compliance.
Consider these two important compliance requirements:
- “An equipment inventory and incident history is maintained.” (CMS Regulations 482.53.)
- “The hospital maintains either a written inventory of all medical equipment or a written inventory of selected equipment categorized by physical risk associated with use (including all life-support equipment) and equipment incident history. The hospital evaluates new types of equipment before initial use to determine whether they should be included in inventory.” (The Joint Commission, EC02.04.01, EP2.)
Together, these two requirements mean that hospitals must establish a current and precise inventory of all medical equipment, and document maintenance and preventive maintenance, regardless of ownership (that is, whether equipment is leased, rented, physician-owned, hospital-owned, or loaned). Although regulatory bodies do not specify how the inventory is documented, the best practice for storing inventory data is through a computerized maintenance management system (CMMS) that stores information in one location, maintains the complete list of inventory and its history on file, and is easily accessible at any given moment.
Preventive Maintenance Frequencies
After properly managing inventory, the next important step to staying compliant is the management of preventive maintenance frequencies. Let’s start as before with the key regulations:
- “The hospital identifies the activities, in writing, for maintaining, inspecting, and testing for all medical equipment on the inventory.” (The Joint Commission, EC02.04.01, EP3.)
- “The hospital identifies in writing, frequencies for inspecting, testing, and maintaining medical equipment on the inventory based on criteria such as manufacturers recommendations, risk levels or current hospital experience.” (The Joint Commission, EC02.04.01, EP4.)
Because these regulations, like many others, are deliberately vague, they leave much to the interpretation of the facility. But as we mentioned in the beginning of this article, interpretation involves significant risks. For instance, recent changes in the CMS preventive maintenance directive now make the interpretation of whether a device is considered life support, critical care, or general dependent on where that device is located in the hospital and how it is used. Let’s look at the following scenario:
For automated external defibrillators in a medsurg unit, some manufacturers do not specify a preventive maintenance frequency. Some clinical engineers therefore decide not to put it on schedule because there isn’t a manufacturer’s requirement. However, because of its location, the device is, under the CMS regulation, now considered a life support device. If a patient crashes and the defibrillator is not operable, the consequences may be dire. For that reason, you should conduct a PM twice a year. Otherwise, you risk a citation or request for improvement from The Joint Commission or your state department of health. The lesson here is that the definition of life-support and critical devices is no longer limited to ventilators and anesthesia, but can include other less obvious devices, such as radiographic imaging and patient monitoring.
Whether for life support or critical care, both types of equipment now must follow the OEM’s recommended PM frequency, regardless of which state you are operating within. The PM frequencies for equipment that is not for life support or critical care can be based upon risk, as long as the hospital is not located in a “non-risk state.” But in the states of Alabama, California, Georgia, Indiana, Louisiana, and New York, facilities must follow the OEM-recommended PM frequencies unless a waiver has been executed and approved by the state department of health.
Additionally, all PM procedures must follow manufacturer-documented procedures regardless of equipment type, according to the CMS. This is a significant change for the industry. It places a huge strain on the clinical engineering department, because a PM that used to take 2 hours can now take up to 6!
The key to maintaining compliance with PM frequencies is not only understanding the current regulations, but also having a plan and schedule. Best practices for PM frequencies include developing a plan, documenting the plan, acting on the plan, and updating it based on federal and state changes.
The Bottom Line
As you can see, the roles and responsibilities of documenting medical maintenance requires more than asking a seasoned clinical engineer to help out when time permits. It requires a full-time risk manager or safety officer who works in tandem with clinical engineering to develop a medical equipment maintenance plan, document inventory, and create a PM schedule for every device in the hospital.
Further, this professional must know when the surveys will take place so that the department is prepared for it and not scrambling at the last minute to find data. While state surveys occur every year, CMS happens about every 15 months, and Joint Commission surveys occur every 18 months to 3 years. The process and requirements for each state and each regulatory body vary, so it is imperative that the risk manager or safety officer understand the timing, process, and requirements for each governing body.
If hiring a full-time professional for this role is not in the budget, consider partnering with a service provider that can help you prepare for the surveys and stay compliant year-round. Regardless of how you approach the challenge, it is critical for every healthcare technology management department to fully understand the regulatory requirements and how they affect their facilities. 24×7 September 2013
Dale Hockel is senior vice president of operations and Denisa Lambert is regulatory affairs & regulatory compliance specialist for TriMedx, Indianapolis. For more information, contact [email protected].